Achieving GINA/NIH guideline-based asthma control with salmeterol/fluticasone compared with fluticasone alone: The results of the GOAL study☆

Abstract Rationale Whether asthma control as defined by GINA/NIH guidelines can be achieved remains unclear. The 1-year Gaining Optimal Asthma controL (GOAL) study investigated whether guideline-based control is achievable, and in what proportion of patients, with salmeterol/fluticasone compared with fluticasone alone. Methods Patients with uncontrolled asthma were stratified into 3 strata based upon prior medication (ICS-naive [S1]/low-dose ICS [S2]/moderate-dose ICS [S3]), and randomized to either salmeterol/fluticasone propionate (Seretide®/Advair®; SFC) or fluticasone propionate (Flixotide®/Flovent®; FP). Doses were stepped up every 12 weeks until Total Control was achieved (or maximum dose reached). Well-Controlled status (derived from 7 goals of the GINA/NIH guidelines) was evaluated over the last 8 weeks of each 12-week treatment period. Results 3421 patients were randomized to treatment; mean age 40 years (SD: 16.2), FEV1 77% predicted at baseline. Significantly more patients achieved Well-Controlled asthma with SFC vs FP alone in all strata: S1: 71% vs 65% (p=0.039); S2: 69% vs 52%; and S3: 51% vs 33%, respectively (S2 and S3; p Conclusions Salmeterol/fluticasone treatment enabled significantly more patients to achieve GINA/NIH guideline-based asthma control at a lower dose of ICS compared with fluticasone alone, in both ICS-naive and those already on ICS, and should therefore become the preferred treatment for all patients with uncontrolled asthma